Patentability and Validity: Subject Matter, Novelty, Obviousness and Utility
This domain tests the substantive validity tests under Canadian law: whether the claimed subject matter falls within s. 2, whether it is novel under s. 28.1, non-obvious under s. 28.2, and useful under s. 28.3. Expect scenario questions asking you to identify which validity attack succeeds on given facts.
Subject matter
- Section 2 categories: art, process, machine, manufacture, composition of matter, and improvements. Canadian law has no statutory exclusions for software, business methods or higher life forms, but the Supreme Court in Harvard College v. Canada (2002) held higher life forms are not patentable subject matter; the Amazon.com decision (FCA 2011) held that a "practical application" of a business method can be an "art."
- Section 27(8) excludes mere scientific principle or abstract theorem. Claims must not monopolize a principle.
- Medical use claims: "use of X for the treatment of Y" and Swiss-type "use of X in the manufacture of a medicament for Y" are both accepted post-2019.
Novelty (s. 28.1)
- Prior art is any disclosure available to the public before the claim date, anywhere in the world.
- Grace period: s. 28.1(1)(a)-(b) - disclosures by the inventor or by someone who obtained the information from the inventor within 12 months before the claim date do not defeat novelty. This is narrower than the US grace period.
- Section 28.1(2) codifies the "whole contents" approach for co-pending Canadian applications with earlier claim dates.
Obviousness (s. 28.2)
- The Windsurfing/ Pozzoli four-step test as adopted in Sanofi and codified in 2019: (1) identify the skilled person and common general knowledge; (2) identify the inventive concept; (3) identify the differences; (4) ask whether those differences would have been obvious to the skilled person, including whether they "could have been adapted" without undue burden.
- "Obvious to try" applies where there are a finite number of predictable solutions.
Utility (s. 28.3)
- The invention must be useful as claimed at the claim date. Apotex v. Wellcome (2002) and AZT confirm that a scintilla of utility suffices, but the utility must be disclosed or soundly predicted.
- Sound prediction requires: a factual basis, an articulable reason, and proper disclosure.
Worked example
A claim recites a compound for treating hypertension. The specification discloses in vitro data only. The examiner rejects under s. 28.3. Analysis: the claim is a medical use claim; utility requires the compound to be useful for treating hypertension at the claim date. In vitro data may support a sound prediction if the specification articulates the reason the in vitro activity predicts in vivo efficacy and discloses the factual basis. If the specification is silent on the predictive link, the utility requirement fails.
Traps
- Applying the US 12-month grace period broadly; Canada's grace period is inventor-specific.
- Treating "obvious to try" as a standalone test rather than a factor within step 4.
- Confusing lack of utility with lack of sound prediction; they are distinct but related.
- Ignoring the claim date vs. filing date distinction when assessing prior art.